FDA 510(k) Application Details - K073363

Device Classification Name Warmer, Thermal, Infusion Fluid

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510(K) Number K073363
Device Name Warmer, Thermal, Infusion Fluid
Applicant PALADIN BIOMEDICAL CORPORATION
506 BOSTON POST ROAD
WESTON, MA 02493 US
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Contact ROBERT BICKFORD
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Regulation Number 000.0000

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Classification Product Code LGZ
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Date Received 11/30/2007
Decision Date 03/20/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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